Trial Acronym

SORMAIN

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URL of the Trial

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Brief Summary in Lay Language

The aim of this clinical trial is to investigate the effect of a drug on the relapse in acute myeloid leukaemia after treatment of the patients with chemotherapy and additional stem cell transplantation. Remaining of leukaemia-cells in the bone marrow can lead to relapse, what is tried to prevent by giving oral application of Sorafenib. Sorafenib is an “inhibitor of kinases”, what are a class of proteins that are involved in the growth of cells. One member of this class is the so called Flt3 ITD protein what is the product of a genetic damage which leads to uncontrolled growth of leukaemia-cells.Because Sorafenib inhibits effectively Flt3-ITD, leukaemia-cells but not other blood-cells are eliminated. Therefore only patients who have shown the Flt3-ITD protein are chosen for treatment.Due to the fact that the therapy with Sorafenib is without the adverse event like chemotherapy, it can be realised continuously and so decrease more and more the number of leukaemia-cells. Together with the outcome by the new immune-system given by the transplanted cells the Sorafenib-therapy give hope of a minimised rate of relapse.

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Brief Summary in Scientific Language

The aim of this study is the comparison of the relapse free survival (RFS) of Flt3-ITD+ AML patients in complete hematological remission after allo-SCT receiving Sorafenib maintenance therapy versus placebo.The following differences between the Sorafenib and placebo branches are to be investigated: a) the median of Overall survival (OS), b) the mean value of RFS and OS depending on the status of NPM1 mutations, c) the mean value of RFS and OS depending on the level of Flt3 expression at baseline and d) the toxicity. It should proceed a longitudinally examination of biomarkers that are associated with response or resistance for Sorafenib and the correlation of these biomarkers to RFS and OS.The safety of Sorafenib should be analysed in regard to the nature and severity (according to NCI CTC 4.02).

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Organizational Data

DRKS-ID:
DRKS00000591

Date of Registration in DRKS:
2010/10/26

Date of Registration in Partner Registry or other Primary Registry:
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Primary Outcome

Relapse free survival (RFS), 50 events (relapse)RFS is defined as time interval from randomization until relapse of AML or death from any cause, which ever occurs first. Relapse is defined as any blast appearance in the peripheral blood, in the bone marrow (> 5%) or extramedullary blasts (chloroma). For a patient with no relapse before the end of study follow-up, observation of RFS will be censored at the date of his or her last follow-up examination.

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Secondary Outcome

Overall survivalOverall survival is defined as time from randomization to the day of death. For a patient who is not known to have died by the end of follow-up, observation of OS will be censored on the date the patient was last known to be alive.

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Countries of Recruitment

DE:
Germany

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Locations of Recruitment

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Recruitment

Planned/Actual:
Actual

(Anticipated or Actual) Date of First Enrollment:
2010/10/29

Target Sample Size:
200

Monocenter/Multicenter trial:
Multicenter trial

National/International:
National

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Inclusion Criteria

Gender:
Both, male and female

Minimum Age:
18
Years

Maximum Age:
no maximum age

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Additional Inclusion Criteria

• Written informed consent • Age ≥18 y. • ECOG performance ≤ 1• FLT3-ITD-positive AML • Complete hematological remission (CHR) after allo-SCTCHR must be confirmed by bone marrow analysis within 14 days before randomization (CHR criteria are: ≤ 5% marrow blasts, no peripheral blasts, blood platelet count > 100/nl, WBC count > 3 G/L, ANC > 1000 G/l).• Allo-SCT with a HLA-identical allo-family donor (FAM) or a matched unrelated donor (MUD) with up to 1 antigen mismatch acceptable (9/10)• Time point of study treatment start of patients in CHR: between d+60 up to d+100 after allo-SCT• Adequate organ function: Serum creatinine ≤ 1.5 x upper normal valueALT, AST, AP ≤ 2.5 x upper normal valueTotal bilirubin ≤ 1.5 x upper limit of normalPT-INR/PTT ≤1.5 x upper limit of normal • • Patients who are being therapeutically anticoagulated with an agent such as Coumadin or Heparin will be allowed to participate in the trial provided that the medical need for anticoagulation is evidence-based (level 1 evidence) and PT-INR and PTT values are closely monitored to maintain the therapeutic window.• Negative serum pregnancy test within seven days prior to first dose in women of child-bearing potential (WOCBP)• WOCBP must use a double barrier method of contraception during the study and for 3 months following the last dose of study drug. WOCBP are defined as sexually mature women who have not undergone a hysterectomy or surgical sterilization or who have not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months).• Male subjects whose sexual partners are WOCBP must use a double barrier method of contraception, one of which includes a condom, during the study and for 3 months after the end of treatment.